Dental implants have very high survival rates and are the fastest growing field in dentistry. But, high complication rates result in significant morbidit, cost, and disappointment. Better pre-operative knowledge of soft tissue thickness and hard tissue contour could dramatically cut complication rates. Current soft tissue thickness measurement techniques for implant procedures involve somewhat inaccurate mechanical penetration of delicate tissues with probes or radiography which is not optimal for soft tissue measurement. A noninvasive ultrasound imaging system is proposed that can potentially improve implant procedures by enabling: accurate non-invasive preoperative measurement of soft tissue thickness, including grafts; identification of important surface bony features such as foramina; identification of bony defects or dehiscences on teeth before extraction, or implants after placement; facilitate intra-operative redirection of the initial drill should a cortical bony perforation occur; and precise location of buried healing implants with measurement of overlying soft tissue. Ultrasound is ideally suited to this purpose because: it can be used in real-time before or during surgeries; data is located to the exact site being imaged on the patient, as directly viewed by the dentist; it is non-invasive and without ionizing radiation; and it can be performed with an inexpensive portable instrument. If successful, the ultrasound system is expected to lower the overall societal cost of implant therapy by decreasing the need for expensive adjunctive procedures necessitated by surgical, esthetic and prosthetic complications. Additionally, the system will improve the quality and predictability of routine implant outcomes (especially facilitating minimally invasive flapless surgery) - important to both dentists and patients. The objective of this Phase II SBIR effort is to demonstrate the clinical efficacy of a customized noninvasive ultrasound imaging system, ImSight, for dental implant procedures. The proposal will focus on fabrication of customized ImSight probes, in-vitro learning studies, in-vitro optimization studies of probe embodiments, clinical trials, and regulatory testing of the ImSight device. The system will be used for treatment planning prior to surgical placement of dental implants, during surgical implant placement, during their subsequent surgical uncovery, and for long-term monitoring. PUBLIC HEALTH RELEVANCE: Dental implants have very high survival rates and are the fastest growing field in dentistry, but are currently beset by high complication rates resulting in the need for a great many adjunctive procedures and less than optimal functional and esthetic outcomes. A noninvasive ultrasound imaging system has the potential to improve site assessment, treatment planning, surgical procedure, uncovery, and monitoring, by enabling accurate identification and measurement of soft tissue thicknesses, bony defects, tooth and implant dehiscences, mental and other foramina, jawbone form, and the precise location of buried healing implants. If successful, the inexpensive system is expected to lower the overall societal cost of implant therapy, facilitate minimally invasive flapless surgery, and improve the quality and predictability of routine implant outcomes - important to both dentists and patients.